Catalog Number

17264

Brand Name

Ameda, Inc.

Version/Model Number

17264

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MGQ

Product Code Name

Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Public Device Record Key

e1b43a80-1224-4282-9e0b-57849e1a8563

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

November 18, 2016

Package DI Number

10810725022273

Quantity per Package

50

Contains DI Package

00810725022276

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Carton